FDA Clearance for Tissue Nanotransfection Treatment?

Ready for human trials?

New Hope for Cell Damage and Repair

It should be noted that FDA approval can take years, so some of the first TNT treatments may take place in foreign nations where such treatments are more quickly cleared through the clinical trial process.

The Food and Drug Administration may take a while to review a promising treatment, but there are protocols to rush research through if it shows a great benefit. However, as the news of this nanotechnology is still fresh, special care must be taken to ensure that it will work for so many different maladies.

Trials necessary

Medical Device or Treatment Option?

Regulatory hurdles will have to be overcome to determine how the treatment is used and potential pitfalls. As with any treatment regimen in its infancy, it may take time to see all the ways this nanotechnology can be used to prolong life and ease suffering. Most importanly, the treatments cannot be harmful to the patient or produce overly negative outcomes. The FDA has been regulating medicines and medical devices for over a century, and has developed systems that are often bureaucratic but also necessary to insure that quack devices and medicines do not make it onto the market. There are usually multiple trials, a great deal of research, and peer-reviewed findings necessary for approval. In some cases, this can lead to delays for things like cancer treatments, drugs to slow symptoms of viruses, and implantable devices. However, if you watch enough daytime TV, you already know how many class-action lawsuits exist for approved devices and drugs, so naturally people will want to get nano devices right before investing billions in taking them to market.